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New treatment option for Atopic Dermatitis
Official title Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
ClinicalTrials.gov ID: NCT07441395
What this study is testing
What is Soquelitinib?
Soquelitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atopic dermatitis.
Also referred to as CPI-818.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to see how well different doses of soquelitinib work in participants with atopic dermatitis (AD) as compared to a placebo (pill with no medicine in it). To check this, the study doctors will examine participants' skin regularly to track how their AD changes during the study.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.
- Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.
- Moderate to severe disease at screening and pre-randomization on Day 1 defined by:
- EASI ≥16
- Body surface area ≥10%
You likely can't join if
- Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that...
- Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment...
- History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the...
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic...
See the full eligibility criteria
- Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.
- Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.
- Moderate to severe disease at screening and pre-randomization on Day 1 defined by:
- EASI ≥16
- Body surface area ≥10%
- vIGA ≥3
- PP-NRS average score of ≥4 over a period of 7 days prior to randomization at Day 1.
- Documented history of prior topical and/or systemic therapy for AD within 6 months of randomization.
- A female participant is eligible if she is not pregnant or breastfeeding, and is either of non-childbearing potential, OR of childbearing potential and agrees to use highly effective birth control
- Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that could interfere with the appropriate assessment of AD lesions.
- Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline.
- History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the opinion of the investigator would interfere with the participant's...
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant...
The study team makes the final eligibility decision.
Where it's taking place
- South San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.